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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96755

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Silex Medical, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.

Z-1893-2025
Recall number
Z-1893-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5860020. UDI-DI: B33158600200. Lot Number: M28181. Serial Numbers: 0691, 0692.

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 2 of 8

Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.

Z-1894-2025
Recall number
Z-1894-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 3 of 8

Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.

Z-1895-2025
Recall number
Z-1895-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5862100. UDI-DI: B33158621000. Lot Number: M28183. Serial Numbers: 1932, 1933, 1934, 1935, 1936, 1937, 1938, 1939.

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 4 of 8

Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.

Z-1896-2025
Recall number
Z-1896-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5863020. UDI-DI: B33158630200. Lot Number: M28184. Serial Numbers: 2222, 2223, 2224, 2225, 2226, 2227, 2228, 2229, 2230, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2238, 2239, 2240, 2241, 2242, 2243, 2244, 2245, 2246, 2247, 2248, 2249, 2250, 2251, 2252, 2253

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 5 of 8

Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

Z-1897-2025
Recall number
Z-1897-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5863030. UDI-DI: B33158630300. Lot Number: M28185. Serial Numbers: 0446, 0447, 0448, 0449, 0450, 0451.

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 6 of 8

Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.

Z-1898-2025
Recall number
Z-1898-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5863050. UDI-DI: B33158630500. Lot Number: M28186. Serial Numbers: 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 7 of 8

Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.

Z-1899-2025
Recall number
Z-1899-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
105 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5864000. UDI-DI: B33158640000. Lot Number: M28187. Serial Numbers: 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9609, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9669, 9670.

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

device · product 8 of 8

Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.

Z-1900-2025
Recall number
Z-1900-2025
Initiated
January 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Silex Medical, LLC
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Code information

Model/REF Number: 5881033. UDI-DI: B33158810330. Lot Number: M28188. Serial Numbers: 0107, 0108.

Distribution pattern

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.